Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
As antibiotic resistance increases over the years, originally established susceptibility breakpoints (S-I-R) are becoming less relevant. This ‘creep’ towards higher MICs over time is a unique but well-known feature of antimicrobials ultimately making these drugs obsolete. In the past, FDA and CLSI did not bother to update breakpoints in Continue reading The Breakpoint Dilemma
It was clear from the outset that the new roster of HCV drugs would change the playing field. Gilead’s NS5B polymerase inhibitor sofosbuvir and J&J’s NS3/4A protease inhibitor simeprevir have already revolutionized the treatment paradigm, pushing telaprevir and boceprevir, the first-generation PIs, to the sidelines. For treatment-naïve patients with GT1, Continue reading So Many HCV “Guidelines”: Can’t We Wait Till the Dust Has Settled?
Several articles in the April 7 issue of BMJ were devoted to the epic battle fought by BMJ and Cochrane to gain unfettered access to the Tamiflu® and Relenza® data. Not just some data, but all the data. Considering that only 2 out of 10 Tamiflu studies were published in Continue reading The War about Data Access